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MDR 2017/745 CERTIFICATION

Enhancing Product Quality Standards
Case study: SANTAGOSTINO
New Features – January 2025

We are proud to announce that our diagnostic imaging software, ZEEROmed VIEW, obtained the CE mark according to the European Medical Device Regulation 2017/745 (MDR).

CERTIFICAZIONE MDR 2017/745
This certification confirms our product’s compliance with the highest safety and quality standards required for Medical Devices, reaffirming our commitment to innovation and patient safety.

The new Regulation establishes more detailed and stringent evaluation criteria, aimed at ensuring maximum transparency and reliability.

Among the new requirements are specific criteria for:

  • technical documentation
  • a Quality Management System for manufacturers
  • a thorough review of clinical evaluations, with particular emphasis on quality.

Additionally, post-market surveillance is implemented, ensuring that product monitoring is continuous and proactive.

CERTIFICAZIONE MDR 2017/745

Thanks to the MDR certification, healthcare professionals can use our software with complete confidence, knowing that every aspect of its design and production has been rigorously assessed and approved.

This certification is an important step in our ongoing commitment to providing reliable, cutting-edge technologies that enhance the quality of medical care in Europe and beyond.

Learn more about our certifications
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